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  • FDA announces reorganization and CTAGTAC votes on Duchenne muscular dystrophy and melanoma therapies
    The FDA disclosed a major internal reorganization aimed at streamlining its operations and improving efficiency across its divisions. The agency’s Cellular, Tissue, and Gene Therapies Advisory Com…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Senate advances Erica Schwartz’s CDC director nomination to full Senate vote
    The Senate Health Committee approved Erica Schwartz as the nominee for CDC director, securing bipartisan support that included every Republican member and Democrat Tim Kaine. With the committee’s…
    STAT · 3mo agoRegulatoryNeutral↗ source
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  • Opinion: Limb girdle muscular dystrophy patients face a maddening reality
    “Too often, regulatory tools authorized to speed patient access to breakthrough treatments are being used in ways that even prevent approval,” writes Kat Bryant Knudson.
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Syphilis cases rise among unhoused drug users at San Diego-Tijuana border as researchers face NIH limits and penicillin shortage
    Researchers at the University of California San Diego have been working for years to build trust with unhoused people who use drugs on both sides of the San Diego‑Tijuana border. Their outreach has…
    STAT · 3mo agoNegative↗ source
  • ADA’s reputation erodes after controversial physician expulsions at annual meeting
    In a recent opinion piece, Adam Marcus and Ivan Oransky reflect on how their view of the American Diabetes Association (ADA) has shifted. Nine years ago they lauded the organization for defending a…
    STAT · 3mo agoNegative↗ source
  • FDA releases draft guidance on container closure and device components for biosimilar combination products
    The FDA issued draft guidance aimed at helping sponsors develop container closure systems and device constituents for biosimilar and interchangeable biosimilar combination products. The guidance f…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Authors rebut mischaracterization of their 2023 Lancet Covid study in recent op-ed
    The authors of a 2023 Lancet analysis on the United States Covid response wrote to correct a recent First Opinion piece that they say misrepresented their work. While they welcome calls for additio…
    STAT · 3mo agoNegative↗ source
  • Bexorg names Bruce Car as new chief scientific officer
    Bexorg announced the appointment of Bruce Car as its chief scientific officer, according to a recent STAT+ column that tracks personnel moves in the pharmaceutical sector. Car joins Bexorg to lead…
    STAT · 3mo agoPositive↗ source
  • Bristol Myers pushes Cobenfy Alzheimer’s psychosis readout to early 2027 after enrollment delays
    Bristol Myers Squibb said the Phase 3 readout for its Cobenfy Alzheimer’s psychosis program will be postponed to early 2027. The company had previously expected data from the three Adept trials to…
    Fierce Biotech · 3mo agoNegative readoutNegative↗ source
  • J&J invests $785M in Sail Biomedicines, secures option to buy for $2.58B
    Johnson & Johnson has agreed to pay $785 million up front to Sail Biomedicines, including a $465 million equity infusion and up to $140 million in milestone payments. The agreement also gives J&J a…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • Replimune's melanoma virus therapy wins FDA advisory committee vote after two rejections
    Replimune's oncolytic virus RP1, also called vusolimogene oderparepvec and Tudriqev, has been rejected twice by the FDA. Today an advisory committee voted 10 to 3 that the candidate shows enough ef…
    Fierce Biotech · 3mo agoRegulatoryPositive↗ source
  • Rising oil prices could lift manufacturing costs of an HIV drug, Unitaid report says
    Rising oil prices, driven in part by geopolitical tensions, have raised concerns about the stability of medicine supply chains. Analysts note that higher energy costs can translate into increased p…
    STAT · 3mo agoNeutral↗ source
  • FDA panel rejects Capricor's Duchenne drug, citing insufficient efficacy data
    The U.S. Food and Drug Administration advisory committee voted 9-to-3 against a Capricor Therapeutics candidate for Duchenne muscular dystrophy. The panel said the clinical data did not provide sub…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Ebola cases approach key milestone as vaccine candidates draw near completion
    The latest update on the Ebola outbreak indicates that the number of cases is approaching a significant threshold, while vaccine development efforts are reported to be close to delivering a usable…
    STAT · 3mo agoNeutral↗ source
  • BMS CEO says firm not pressured to pursue acquisitions despite quiet M&A year
    BMS chief executive Chris Boerner told analysts on the second‑quarter earnings call that the company’s robust late‑stage pipeline means it does not feel any compulsion to chase deals. The firm has…
    Fierce Biotech · 3mo agoDealNeutral↗ source
  • Labcorp reports Q2 sales of $3.73 billion, lifts full-year revenue outlook despite missing consensus
    Labcorp announced second‑quarter revenue of $3.73 billion, up from $3.53 billion a year earlier, driven by strong performance across its core businesses. The Diagnostics division grew 5.5% to $2.9…
    Fierce Biotech · 3mo agoEarningsNeutral↗ source
  • Takeda drops its second celiac disease candidate, TAK-101, after unimpressive phase 2 results
    Takeda said it is halting development of TAK-101, its second candidate for celiac disease, after a phase 2 study failed to meet expectations. TAK-101 is a nanoparticle that carries gliadin, a glut…
    Fierce Biotech · 3mo agoNegative readoutNegative↗ source
  • GSK signs up to $110 million AI data partnership with Relation
    GSK announced a research collaboration with AI-focused biotech Relation, valued at up to $110 million. Under the agreement Relation will produce large-scale datasets that capture how human cells r…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • Sanofi’s new CEO vows deeper review of late-stage pipeline after series of trial failures
    Sanofi appointed Belén Garijo as chief executive in February with a clear mandate to tighten R&D governance and boost productivity. The board tasked her with bringing more rigor to the company’s st…
    Fierce Biotech · 3mo agoNegative readoutNegative↗ source
  • Argon Medical issues correction for convenience kits containing lidocaine ampules after FDA safety alert
    Argon Medical has sent a correction notice to customers about certain convenience kits that include lidocaine HCl ampules supplied by Spectra Medical Devices. The FDA has classified this correctio…
    fda medwatch · 3mo agoCRLNegative↗ source
  • Boston Scientific lowers full-year revenue outlook as restructuring plan targets slowing growth
    Boston Scientific announced on July 29 that it is cutting its 2026 full-year organic revenue growth forecast to 5-6%, down from the prior 6.5-8% range. The revision follows a second consecutive qu…
    Fierce Biotech · 3mo agoEarningsNegative↗ source
  • FDA releases FY 2027 user fee rates for prescription, generic, biosimilar, device and over the counter programs
    The U.S. Food and Drug Administration has published its user fee schedule for fiscal year 2027. The rates cover prescription drugs, generic drugs, biosimilars, medical devices and over the counter…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA releases updated guidances for injectable peptide drugs and announces FY 2027 user fee rates
    The FDA has updated 17 draft product-specific guidances aimed at helping sponsors prepare abbreviated new drug applications for injectable peptide products. The guidances cover peptide therapies u…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Study Finds Accelerated Approval Rarely Used for Adult Cancer Drugs Over Past 20 Years
    A new analysis published in JAMA shows that most adult oncology medicines approved by the FDA in the last two decades received standard approvals for expanded uses, relying on surrogate endpoints r…
    raps · 3mo agoNegative↗ source
  • FDA releases FY 2027 user fee rates and updates guidance for injectable peptide ANDAs
    The U.S. Food and Drug Administration has published its user fee rates for fiscal year 2027, covering prescription drugs, generics, biosimilars, medical devices and over‑the‑counter products. The r…
    raps · 3mo agoRegulatoryNeutral↗ source